510(k) · Cleared
ClearedSCARLET® AC-T Secured Anterior Cervical Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineart · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Feb 23, 2015 as substantially equivalent to K141314 (Spineart, 2014) and 4 other predicates after a 105-day review. Its family tree reaches back 15 generations to 1984. 3 later devices descend from it.
- Decided
- Feb 23, 2015
- Review
- 105 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K841189 (1984). 112 ancestors in all, the oldest K792352 (1979). 3 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 2 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 1 generation backK141314 Scarlet AC-T Secured Anterior Cervical Cage and Associated…Spineart · 2014
- This deviceK143214 SCARLET® AC-T Secured Anterior Cervical CageSpineart · 2015
- Descendant · cites it directly · 2 of its ownK172065 Scarlet AC-TSpineart · 2017
- Descendant · cites it directly · 1 of its ownK190322 SCARLET® AC-T Secured Anterior Cervical CageSpineart · 2019
- Descendant · cites it directly · 0 of its ownK240699 SCARLET® AC-TiSpineart SA · 2024
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 9 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 8 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 7 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 5 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 4 generations backK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- 3 generations backK092211 Chesapeake Spinal SystemK2m, Inc. · 2010
- 2 generations backK111439 Chesapeake (Cervical Components)K2m, Inc. · 2011 · Recalled
- 1 generation backK141314 Scarlet AC-T Secured Anterior Cervical Cage and Associated…Spineart · 2014
- This deviceK143214 SCARLET® AC-T Secured Anterior Cervical CageSpineart · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −9 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −8 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −7 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −5 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −4 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| −3 | K092211 | Chesapeake Spinal System | K2m, Inc. | 2010 | — |
| −2 | K111439 | Chesapeake (Cervical Components) | K2m, Inc. | 2011 | 1 |
| −1 | K141314 | Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation | Spineart | 2014 | — |
| 0 (this device) | K143214 | SCARLET® AC-T Secured Anterior Cervical Cage | Spineart | 2015 | — |
| +1 | K172065 | Scarlet AC-T | Spineart | 2017 | — |
| +1 | K190322 | SCARLET® AC-T Secured Anterior Cervical Cage | Spineart | 2019 | — |
| +1 | K240699 | SCARLET® AC-Ti | Spineart SA | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 18 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 7 | 0 |
| 2008 | 13 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141314 | Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSummary page 4…TRADITIONAL ® Basis for submission Extension of the range of SCARLET AC-T devices cleared under K141314 SPINEART International Center Cointrin 20 rou… | 2014 |
| * | K120819 | Stalif CSummary page 4…LIF C Cervical Intervertebral Body Fusion Cage ® Legally marketed (K120819) manufactured by CENTINEL SPINE, INC; Chesapeake cervical-Ti Stabilization predicate devices system (K111439) manufactu… | 2012 |
| * | K111439 | Chesapeake (Cervical Components)Summary page 4…® Legally marketed (K120819) manufactured by CENTINEL SPINE, INC; Chesapeake cervical-Ti Stabilization predicate devices system (K111439) manufactured by K2M, INC; Zero-P anterior cervical interbody fusion… | 2011 |
| * | K112459 | Synthes Zero-PSummary page 4…Zero-P anterior cervical interbody fusion ® device (K112459) manufactured by SYNTHES SPINE; AVS Anchor-C Cervical Cage System (K102606) manufactured by STRYKER S… | 2011 |
| * | K102606 | Avs Anchor-C Cervical Cage SystemSummary page 4…® device (K112459) manufactured by SYNTHES SPINE; AVS Anchor-C Cervical Cage System (K102606) manufactured by STRYKER SPINE ®… | 2011 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 12 companies; a new generation was cleared every 1.0 years on median.
- 14 of the 112 ancestors have a recall of any class.
- Of its descendants, K172065 (Spineart, 2017) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K141314.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The SCARLET®AC-T is intended to be used as an intervertebral body fusion cage as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic…
Read the full statement (121 words)
The SCARLET®AC-T is intended to be used as an intervertebral body fusion cage as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. SCARLET®AC-T is intended to be used at one level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143214: SCARLET® AC-T Secured Anterior Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143214
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026